Last updated on May 2019

Hepatocellular Carcinoma Study Comparing Vaccinia Virus Based Immunotherapy Plus Sorafenib vs Sorafenib Alone


Brief description of study

This is a randomized Phase 3 study to determine whether treatment with vaccinia virus based immunotherapy (Pexa-Vec) followed by sorafenib increases survival compared to treatment with sorafenib in patients with advanced hepatocellular carcinoma who have not received prior systemic therapy.

Detailed Study Description

This is a multi-center, randomized, open-label, Phase 3 study comparing Pexa Vec followed by sorafenib versus sorafenib in patients with advanced HCC without prior systemic therapy.

A total of 600 patients will be randomly assigned to 2 treatment arms in a 1:1 ratio (300 in each arm) to reach at least 570 evaluable patients.

Clinical Study Identifier: NCT02562755

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University of Alabama

Birmingham, AL United States
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Mayo Clinic Arizona

Scottsdale, AZ United States
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UC Irvine Medical Center

Orange, CA United States
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University of Louisville

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Mercy Medical Center, Inc.

Baltimore, MD United States
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Minneapolis, MN United States
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Kansas City Research Institute

Kansas City, MO United States
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Saint Louis University

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Billings Clinic

Billings, MT United States
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Morristown Medical Center

Morristown, NJ United States
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St. Joseph's Hospital

Paterson, NJ United States
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Ohio State University

Columbus, OH United States
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Rhode Island Hospital

Providence, RI United States
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Adelaide, Australia
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Adelaide, Australia
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Brisbane, Australia
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Jerusalem, Israel
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Ramat-Gan, Israel
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Tel Aviv, Israel
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Meldola, Italy
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Ansan, Korea, Republic of
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Bucheon, Korea, Republic of
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Busan, Korea, Republic of
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Daegu, Korea, Republic of
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Daegu, Korea, Republic of
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Recruitment Status: Open


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